Avastin and Erlotinib as First Line Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Advanced Ovarian, Fallopian Tube, and Primary Peritoneal Cancer, and Papillary Serous Mullerian Tumors - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Genentech Beth Israel Deaconess Medical Center Brigham and Women's Hospital Massachusetts General Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00520013

Purpose

The purpose of this research study is to evaluate how patients with newly diagnosed advanced ovarian, fallopian tube, primary peritoneal or papillary serous Mullerian tumor respond to Avastin and erlotinib, or Avastin alone over 1 year. These drugs have been used in the treatment of other types of cancers and information from those studies suggests that these agents may help to treat the cancers studied here.

Condition	Intervention	Phase
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Papillary Serous Mullerian Cancer	Drug: Avastin Drug: erlotinib Drug: paclitaxel Drug: carboplatin	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin Erlotinib hydrochloride Erlotinib Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase II Trial of Avastin (A) or Avastin and Erlotinib (AE) as First Line Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Newly Diagnosed Advanced Ovarian, Fallopian Tube and Primary Peritoneal Cancer & Papillary Serous Mullerian Tumors

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To examine the progression free survival of Avastin and erlotinib (AE) or Avastin (A) as consolidation therapy at predefined time. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To examine the toxicity between the two consolidative regimens AE versus A. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the response to CTA. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Avastin every three weeks for 1 year	Drug: Avastin Given every three weeks for 1 year Drug: paclitaxel Given intravenously on Day 1 of each cycle for 6 cycles (each cycle lasts 21 days) Drug: carboplatin Given intravenously on Day 1 of each cycle for 6 cycles (a cycle lasts 21 days)
2: Experimental Avastin every three weeks for 1 year and erlotinib every day for one year	Drug: Avastin Given every three weeks for 1 year Drug: erlotinib Every day for one year Drug: paclitaxel Given intravenously on Day 1 of each cycle for 6 cycles (each cycle lasts 21 days) Drug: carboplatin Given intravenously on Day 1 of each cycle for 6 cycles (a cycle lasts 21 days)

Detailed Description:

Each treatment cycle lasts three weeks (21 days). Participants will receive only paclitaxel and carboplatin on Day 1 of Cycle 1. They will receive paclitaxel, carboplatin and Avastin for cycles 2-6. All of these drugs are given intravenously.
After participants receive six cycles of treatment with paclitaxel and carboplatin, they will be randomized into one of two study groups. Group 1 will receive treatment with Avastin every 3 weeks for 1 year. Group 2 will receive Avastin every 3 weeks for 1 year and take erlotinib orally every day for 1 year. This second part will occur about one month after the second look surgery (see below).
If there is no cancer seen on a scan that is performed after 6 cycles of paclitaxel, carboplatin and Avastin, second look surgery will be discussed.

The second look surgery is to see if there is any cancer at the end of treatment that was not seen by CT scan or MRI. This surgery will take place about one month after the 6th cycle of treatment if it is recommended.

During all treatment cycles participants will have a physical exam and be asked questions about their general health and specific questions about any problems they are experiencing.
Blood tests including chemistry, hematology, CA-125, as well as other tests to measure any additional effect of the study drug or disease status, will be done prior to each cycle of treatment and during the follow-up period.
Assessment of the tumor by CT scan or MRI will be done as follows: After every three cycles of chemotherapy; every three months during consolidation treatment (treatment with Avastin OR Avastin and erlotinib); every three months after the end of study treatment for 1 year, unless the tumor grows.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age and older
Histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, primary peritoneal carcinoma, or papillary serous mullerian carcinoma
Previous attempted surgical debulking
Stage III or IV
Willing and able to undergo second look laparoscopy
Performance status 0-1 by ECOG scale
Peripheral neuropathy < grade 2
Life expectancy of 6 months or greater

Exclusion Criteria:

Patients with clinically significant cardiovascular disease as outlined in the protocol
Neutrophil count < 1,500/mm3; platelet count <100,000/m3
Alkaline phosphatase or bilirubin > 1.5 x ULN, SGOT > 5 x ULN
Calculated creatinine clearance < 50ml/min
Prior chemotherapy or radiotherapy for other malignancy except for the treatment for localized breast cancer greater than five years prior to diagnosis
No more than one cycle of first line chemotherapy with carboplatin and paclitaxel
Inadequate surgical cytoreduction such that interval cytoreductive surgery could materially improve prognosis
Concurrent invasive malignancy
Evidence of bleeding diathesis or coagulopathy
Evidence of tumor involving major blood vessels on any prior CT scans
Surgical wound that has failed to close
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of this study
Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 0
Serious non-healing wound, ulcer, or bone fracture
Prior treatment with an anti-angiogenic agent
Any active bleeding
Active psychiatric disease or neurologic symptoms requiring treatment
Presence of central nervous system brain metastases
Proteinuria at screening as demonstrated by criteria in protocol
Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent
Known hypersensitivity to Cremophor EL or any component of Avastin
Active bacterial, viral, or fungal infections
Receiving any other investigational agent
History of gastrointestinal perforation
Prior therapies targeting the epidermal growth factor receptor
Symptoms of bowel obstruction
Dependence on TPN or IV hydration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520013

Contacts

Contact: Susana Campos, MD, MPH	617-632-6766	scampos@partners.org
Contact: Kimberley MacNeill	617-632-3743	kmacneill@partners.org

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Susana Campos, MD, MPH
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Richard Penson, MD
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Corrine Lenahan, MD

Sponsors and Collaborators

Dana-Farber Cancer Institute

Genentech

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Massachusetts General Hospital

Investigators

Principal Investigator:

Susana Campos, MD, MPH

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Susana Campos, MD, MPH )
Study ID Numbers:	07-039
Study First Received:	August 22, 2007
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00520013 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Fallopian Tube Cancer
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Bevacizumab
Protein Kinase Inhibitors
Genital Diseases, Female
Peritoneal Diseases
Ovarian Cancer
Endocrine Gland Neoplasms
Erlotinib
Digestive System Neoplasms
Ovarian Neoplasms
Genital Neoplasms, Female

Endocrine System Diseases
Carboplatin
Antimitotic Agents
Abdominal Neoplasms
Angiogenesis Inhibitors
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Endocrinopathy
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Bevacizumab
Protein Kinase Inhibitors
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Endocrine Gland Neoplasms

Erlotinib
Ovarian Neoplasms
Digestive System Neoplasms
Growth Substances
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Abdominal Neoplasms
Angiogenesis Inhibitors
Fallopian Tube Neoplasms
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on May 07, 2009